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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01388257
Other study ID # SNFCP-001
Secondary ID
Status Recruiting
Phase N/A
First received July 4, 2011
Last updated June 6, 2012
Start date October 2011
Est. completion date March 2017

Study information

Verified date June 2012
Source French Society of Coloproctology
Contact Laurent Abramowitz, MD
Phone 140 50 11 22
Email laurent.abramowitz@bch.ap-hop-paris.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate, in patients treated with adalimumab, the efficacy of proctological surgery in anoperineal fistula healing after the removal of seton drain.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date March 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- male or female 18 years or older,

- women of childbearing age who use an effective contraception method or women incapable of becoming pregnant [(i.e. postmenopausal women for 1 year or surgically sterile (hysterectomy and/or bilateral oophorectomy)],

- Patient with fistulizing anoperineal Crohn's disease. Anoperineal fistulas can be associated with ileal, colic or rectal lesions,

- Patient with at least 1 anoperineal fistula drained with a seton for more than 1 month,

- Patient treated with adalimumab for more than 1 month,

- Patient who agrees to undergo surgery for its drained fistula(s),

- Patient with immunosuppressive therapy (azathioprine, 6-mercaptopurine ou methotrexate) stable for at least 3 months or patients without immunosuppressive therapy,

- Patient who gave signed written informed consent after having received verbal explanation and written information related to the trial.

Exclusion Criteria:

- Pregnant or breastfeeding women,

- Patient having a perineal abscess,

- Patient with a high anovaginal fistula that cannot be treated, according to the investigator ,with fistulotomy, gluing, biodegradable plug or advancement flap,

- Patient treated with a daily dose of corticosteroids of more than 20 mg (a dose of more than 20 mg daily will be authorized during the study),

- Contraindication to proctological surgery on the drained fistula(s),

- Patient presenting with somatic or psychic signs or symptoms that are not compatible with his/her participation in the trial according to the investigator,

- Patient who participate in another clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
All types of surgery procedures
All types of surgery procedures used for anoperineal fistula repair. Surgery procedures include fistulotomy, biological glue, rectal advancement flap and plug.
Simple seton drain removal
Patients are simply followed after seton drain removal.

Locations

Country Name City State
France Polyclinique de Franche-Comté - Department of Proctological Surgery Besançon Franche-Comté
France CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology Bordeaux Aquitaine
France Hôpital Louis Mourier - Department of Hepato-Gastroentérologie Colombes Ile-de-France
France Clinique des Cèdres - Hepato-Gastroenterology Department Cornebarrieu Midi-Pyrénées
France Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit Grenoble Rhône-Alpes
France Hôpital Nord de Marseille - Gastroenterology Department Marseille
France Hôpital Bichat-Claude Bernard - Gastro-enterology Department Paris Ile-de-France
France Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology Paris Ile-de-France
France Institut Mutualiste Montsouris - Proctology Unit Paris Ile-de-France
France Hôpital de POISSY Poissy
France CHU Pontchaillou - Department of Digestive Diseases Rennes Bretagne
France CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition Rouen Haute Normandie
France Polyclinique de l'Océan Saint-Nazaire
France Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology Talence Aquitaine
France Clinique Saint Jean Languedoc - Department of Gastroenterology Toulouse Midi-Pyrénées

Sponsors (1)

Lead Sponsor Collaborator
French Society of Coloproctology

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease 12 months after seton drain removal No
Secondary Proportion of patients having more than half of their fistulas healed 3, 6, 12 and 24 months after seton drain removal No
Secondary Change in Crohn disease activity assessed by Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI) 3, 6, 12 and 24 months after seton drain removal No
Secondary Change in anal continence assessed by Wexner and Vaizey scores 12 and 24 months after seton drain removal No
Secondary Crohn's Disease Endoscopic Index of Severity (CDEIS) 12 months after seton drain removal No
Secondary Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) 12 and 24 months after seton drain removal No
Secondary Change in fistula activity assessed by magnetic resonance imaging (MRI) Change in fistula activity assessed by MRI (Van Assche score and absence of contrast enhancement after injection of gadolinium with regards to fistulous tract 6, 12 and 24 months after seton drain removal No
Secondary Change in discomfort and impact assessed by the patient using a visual analog scale (VAS) 3, 6, 12 and 24 months after seton drain removal No
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